Frequently Asked Questions about SpaceOAR Hydrogel
You may have questions about how and why the procedure is done, and what to expect. This section will help to answer many of the questions you may have about the procedure.
The rectum and prostate are in close proximity, which means radiation may cause unintended damage to the rectum, leading to issues with bowel function or other side effects. SpaceOAR Hydrogel, which is designed to create a temporary space between the prostate and the rectum, can help to maintain rectal function.
SpaceOAR Hydrogel is an FDA-cleared implant made of two liquids that when combined, form a soft gel-like synthetic material. The Hydrogel is highly absorbent and predominately water-based, containing over 90% water, and is made with the same FDA-cleared material used in other surgical sealants such as the eye, brain and spine.2
Today, over 50,000 patients have been treated with SpaceOAR Hydrogel and it is used by leading cancer centers around the world.*2
Not only is SpaceOAR Hydrogel used in leading cancer institutions, many radiation oncologists, urologists and interventional radiologists around the world recommend SpaceOAR Hydrogel for their prostate cancer patients.2
Ask your doctor about SpaceOAR Hydrogel or find a SpaceOAR Hydrogel doctor near you with our Find a Doctor Tool
By acting as a spacer, the hydrogel temporarily moves the rectum a half inch (1.3 cm) away from the prostate.3 By separating the prostate from the rectum, SpaceOAR Hydrogel helped to reduce the radiation dose delivered to the rectum and may eliminate or decrease damage.1
SpaceOAR Hydrogel can be implanted as an outpatient procedure in a hospital, surgery center, outpatient clinic or doctor’s office prior to the start of radiation treatment. It is typically not a lengthy procedure.
Your doctor will use a local, regional, or general anesthesia and the injection site will be numbed, so you may feel a pinprick or pressure but should not feel any discomfort.3 Following the implantation, you may experience some temporary discomfort at the injection site. SpaceOAR Hydrogel patients typically report no prolonged discomfort from the implanted gel.
SpaceOAR Hydrogel stays in place, separating your prostate and rectum, for about 3 months.1 After about 6 months, the hydrogel is naturally absorbed into the body and removed in your urine.
As with any medical treatment, there are some risks involved with the use of SpaceOAR Hydrogel. Potential complications associated with SpaceOAR Hydrogel include, but are not limited to: pain associated with SpaceOAR Hydrogel injection; pain or discomfort associated with SpaceOAR Hydrogel; needle penetration of the bladder, prostate, rectal wall, rectum or urethra; injection of SpaceOAR Hydrogel into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR Hydrogel intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. Please talk with your doctor about the risks and benefits associated with the SpaceOAR Hydrogel.
- Mariados N, Sylvester J, Shah D, et al. Hydrogel spacer prospective multicenter randomized controlled pivotal trial: Dosimetric and clinical effects of perirectal spacer application in men undergoing prostate image guided intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):971-7.
- Data on file at Boston Scientific
- Van Gysen K, et al. Feasibility of and rectal dosimetry improvement…J Med Imaging & Rad Oncol 2014 highlights
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling
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